CARSGEN-B(02171): The summary of the trial results of Soriatinib injection for adjuvant treatment of pancreatic cancer has been accepted for a poster presentation at the 2025 ESMO Annual Congress.

CARSGEN-B (02171) announces that the preliminary results of the Phase Ib registration clinical trial (CT041-ST-05, NCT05911217) of the injection of Churigeaioulunsi for the adjuvant treatment of pancreatic cancer (PC) in China have been accepted for poster presentation at the 2025 European Society of Medical Oncology (ESMO) Annual Meeting. The abstract will be published on the ESMO website on Monday, October 13, 2025 at 00:05 Central European Summer Time (CEST). Churigeaioulunsi injection is a potential globally first-in-class autologous CAR-T cell candidate product targeting Claudin18.2 protein for the treatment of Claudin18.2 positive solid tumors, primarily gastric/esophageal junction adenocarcinoma and pancreatic cancer. Ongoing trials include a investigator-initiated clinical trial conducted in China (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced gastric/esophageal junction adenocarcinoma in China (CT041-ST-01, NCT04581473), a Phase Ib registration clinical trial for adjuvant treatment of pancreatic cancer in China (CT041-ST-05, NCT05911217), a investigator-initiated clinical trial for consolidation therapy after adjuvant treatment in postoperative gastric/esophageal junction adenocarcinoma patients in China (CT041-CG4010, NCT06857786), and a Phase Ib/II clinical trial for advanced gastric or pancreatic cancer in North America (CT041-ST-02, NCT04404595). On June 25, 2025, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepted the new drug application (NDA) for the market approval of Churigeaioulunsi injection for the treatment of advanced gastric/esophageal junction adenocarcinoma (G/GEJA) patients expressing Claudin18.2 positive who have failed at least second-line treatment. In May 2025, Churigeaioulunsi injection was included in the priority review by CDE. In March 2025, Churigeaioulunsi injection was granted breakthrough therapy designation by CDE. In January 2022, Churigeaioulunsi injection was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the US FDA for the treatment of Claudin18.2 positive advanced gastric/esophageal junction adenocarcinoma. In September 2020, Churigeaioulunsi injection was granted orphan drug designation by the US FDA for the treatment of gastric/esophageal junction adenocarcinoma.